
SPOREs : Organization for Applicants : Guidelines

Organization of the Organ Systems Branch
Overview, organization, staff listing and contact information

Current SPORE Programs
Abstracts and Cores of currently funded SPOREs

Information for the Public
Information for the public interested in activities of the SPORE program and frequently asked questions

PART Program
Information about the Patient Advocate Research Team Program

Information for Applicants
Information for researchers interested in applying for the SPORE program

IntraSPORE Communications
(access restricted to SPORE Investigators)

GUIDELINES

SPECIALIZED PROGRAMS OF RESEARCH
EXCELLENCE (SPOREs)

ORGAN SYSTEMS BRANCH
OFFICE OF CENTERS, TRAINING, AND RESOURCES
OFFICE OF DEPUTY DIRECTOR FOR EXTRAMURAL SCIENCES
NATIONAL CANCER INSTITUTE

June 2001

SECTION I. GENERAL GUIDELINES

Introduction
SPORE Definition of Translational Research
General Description of the SPORE Program
Funding of SPORE Grants
Eligibility and Required Components
Submission Requirements and Receipt Dates
Review Considerations
Inquiries

SECTION II. SPECIAL INSTRUCTIONS FOR PREPARING A COMPETING SPORE GRANT APPLICATION

General Information
Detailed Directions

SECTION III. SUPPLEMENTAL GUIDELINES FOR PREPARING A NONCOMPETING CONTINUATION SPORE APPLICATION

Introduction
General Issues
Progress Report Summary

SECTION I. GENERAL GUIDELINES

Introduction

Specialized Programs of Research Excellence (SPOREs) were conceived and implemented by the National Cancer Institute (NCI) through a special $20 million appropriation from Congress in Fiscal Year 1992. SPOREs evolved from the original NCI Organ Site Programs, which were organ-specific but without translational research focus, established shortly after the National Cancer Act of 1971. SPOREs represented a strategic response to the rapid expansion of information about cancer being developed through basic research using model systems. At that time, there was no funding mechanism designed exclusively to focus on translational research that would take a systematic approach to exploring which basic research discoveries were potentially the most likely to have an impact on human cancers. In order to address this need, the SPORE Program was initiated by the NCI as an experiment to promote interactions between basic scientists and applied scientists and provide them with the flexibility to rapidly test new approaches to the prevention, early detection, diagnosis and treatment of human cancer.
When the SPORE program was initiated in FY92, Request for Applications (RFAs) were issued that resulted in the funding of four breast cancer SPOREs, two prostate cancer SPOREs and two lung cancer SPOREs. The objective of the SPORE program was and is to encourage a wide range of scientific approaches focused on translational research (see the SPORE definition of translation below). Of particular importance was choosing a grant mechanism (i.e., the P50) that has all of the features necessary to enable SPOREs as translational research instruments. These P50 grants are designed so that every research project is inherently translational: specialized infrastructures are established to support translational research; scientists work as teams rather than as independent investigators; scientists have the flexibility to start and stop research projects without additional peer review; scientists have flexible funds to develop pilot projects and test new technologies in collaboration with scientists in or outside of their institutions; and SPOREs combine their resources to ask questions that no one institution could address alone.

The first P50 SPORE grants were funded for three rather than five years in order to ensure that the translational research concept was working; as the experiment proved more promising, all applicants were allowed to request five years of support. Using the RFA process, the SPORE Program evolved to include five sites: breast, prostate, lung, gastrointestinal and ovary. However, by limiting the submission of SPORE applications to every five years in response to RFAs, the Program was relatively "closed" and unable to capitalize on investigator-initiated scientific opportunities. In addition, the Program was not open to all cancer sites. These issues were discussed with NCI advisory groups. In particular, the NCI Board of Scientific Advisors suggested that the initial results of the SPORE Program were very promising and, although it favored additional evaluation with time, it saw no reason to restrict the expansion of the SPORE Program. As a result, in 1999 the NCI approved restructuring the SPORE program from one that was RFA-driven to one that was investigator-initiated, utilizing a program announcement (PA) open to grant applications for all types of cancers on a scheduled competitive basis.

SPORE Definition of Translational Research

There is currently no consensus definition of translational research. For purposes of the SPORE program the NCI defines it as follows: translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans AND/OR determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer. The term "interventions" is used in its broadest sense to include molecular assays, imaging techniques, drugs, biologicals and/or other methodologies that are relevant to the prevention, early detection, diagnosis, prognosis or treatment of cancer. Translational research in SPOREs is always founded on and directly connected to some aspect of human biology and may encompass any form of cellular, molecular, structural, biochemical, genetic, or other appropriate experimental approach.

SPOREs conduct early-stage interventions to establish the feasibility or proof of principle of specific approaches in cancer. All research projects whose goal is the development and testing of an intervention are expected to reach the feasibility testing stage in humans within the anticipated five-year period of grant support. Similarly, studies that seek to determine the biological basis for an observation in human cancer should do so within five years. Some, but not all, types of behavioral research are appropriate for SPOREs. Biobehavioral research that clearly focuses on links between biological variables, processes, and mechanisms pertaining to behavior or psychosocial variables is appropriate. Psychosocial variables might include cognitions, affect, personality, or interpersonal context or processes (e.g., social support, familial interactions, physician-patient communication). Behavioral research that focuses on psychosocial processes or behavior change without a clear, specific linkage to a biological process (e.g., disease susceptibility, etiology, or progression) is not appropriate. SPOREs are also not the place for definitive validation of new interventions, which are supported by other programs in several divisions of the NCI.

Within the limits of the definitions and time frames outlined above, SPOREs have considerable flexibility in selecting and developing areas of research with the greatest anticipated potential for improving cancer outcomes. Investigators who question whether their research goals adhere to the above definition of translation and/or the expectations of the SPORE Program are advised to consult with NCI program staff in the Organ Systems Branch.

Figure 1.
Translational research focus of a SPORE.
Research projects should be designed to (a) test the relevance of a biological discovery in human cancer risk, prevention, diagnosis, prognosis, or treatment or (b) determine the biological basis of an observation made in the clinic or population within the five-year term of the grant.

General Description of the SPORE Program

Specialized Programs of Research Excellence (SPOREs) utilize the P50 grant mechanism to support interdisciplinary teams of investigators who are dedicated to translational research focused on an organ-specific human cancer (e.g., breast cancer) or a highly related group of human cancer types (e.g., gastrointestinal). SPOREs are open to any scientific approaches that can have an impact on the disease and are dependent upon team approaches in the design and implementation of the research. SPOREs differ from program project grants (P01s) in that SPORE grants focus on human disease and exclusively support translational research, have a flexible approach to starting and stopping research projects, and have a required tissue bank core as well as required programs for career development and developmental projects. In addition to their organ-site orientation, the common features of all SPOREs are the following:
1. Translational Research Focus
  All SPOREs focus on translational research that meets the definition provided in Section I.B. above. The research of a SPORE is dedicated to obtaining experimental results that will have a direct impact on improving approaches to the prevention, detection, diagnosis and/or treatment of human cancer. SPOREs may support basic science projects if the objective of the research will be directly relevant to human cancer and realize a human application during the five year term of the grant. If a project has lost its translational focus or the likelihood of having an impact on human cancer, it should be discontinued and another funding source sought.
2. Collaborative Design and Implementation of Research Projects
  Every project in a SPORE is inherently translational because it is collaboratively designed and executed by basic scientists working at the cellular and molecular levels, physicians experienced in patient-oriented research, and population scientists experienced in studying the patterns of disease.
3. Flexibility to Change Research Direction/Team Approach
  SPOREs continually select the most promising research approaches that are likely to have a more immediate impact on improving cancer prevention, detection, diagnosis, prognosis and/or treatment. The flexibility of the SPORE program promotes the discontinuance of research projects demonstrating little or no translational significance or scientific progress and enables new projects with greater potential to be initiated. While the team of scientists that participates in the SPORE remains largely the same, the lead roles of co-investigators on projects may change through the course of the research.
4. Specialized Research Infrastructure
  SPOREs are expected to develop the critical research infrastructure needed to sustain translational research objectives for projects within the SPORE, as well as for potential collaborative research with other SPOREs and other research groups within the biomedical research community. SPOREs are expected to be in a position to facilitate the complex research objectives inherent in studying human cancer.
5. Fostering Translational Research Careers
  SPOREs provide a unique environment for translational research that can be used to prepare new scientists for careers in this evolving field or provide the opportunity for established scientists to re-orient their research careers toward translational research.
6. Research Collaborations, Networks, and Consortia
  SPOREs are expected to identify the kinds of research questions that can only be accomplished through research collaborations, networks, and consortia. SPOREs collaborate with other scientists in the field to answer research questions that can take full advantage of SPORE scientific expertise and infrastructure. Through the promotion of Inter-SPORE research, SPOREs also conceive and initiate research that is linked to other key programs of the NCI.
7. Sharing Information
  SPOREs readily share information within their organ site network, as well as with other SPOREs, to take advantage of research results that are applicable to various cancer sites.
Funding of SPORE Grants
1. Grant Mechanism
  Support of this program is through the specialized center grant (P50) mechanism employed by the National Institutes of Health. Applicants are responsible for the planning, direction, and execution of the proposed SPORE program. Awards can be made for up to five years and will be administered under NIH grants policy as stated in the NIH Grants Policy Statement.
2. Basis of Funding
  Applications will be awarded on a competitive basis. The following will be considered in making decisions: quality of the application as determined by peer review, availability of funds, and programmatic priorities.
3. Planning Grants
  While applicants cannot apply directly for planning grants (P20s), under special circumstances, the NCI may consider funding a P50 SPORE application at a reduced level for up to two years using the P20 grant mechanism. Circumstances leading to the funding of a P20 rather than a P50 include: (1) the research projects in the SPORE application have high scientific merit but other essential components of the application require further development; (2) the peer review criticisms can be readily addressed within two years; and/or (3) the application meets important NCI program objectives (e.g., the organ site to be studied is under-represented).
4. Expanded Authorities
  Both NCI P50 and P20 grants may be administered by the awardee under Expanded Authorities which can be viewed at: http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#expandauth. The expanded authorities allow additional flexibility to take advantage of research opportunities as they arise throughout the term of the grant. Under the expanded authorities, NIH has waived the requirement for its approval of specified actions under certain awards and has provided the authorities to grantees to take such actions without NIH prior approval. These actions include the carryover of unobligated funds and extensions of the project period without additional funds.
Eligibility and Required Components

Applications must meet all of the following eligibility criteria [items 1(a)-(d)] as well as contain the required components of a SPORE listed in items 2-9 below. Applications that are not responsive to these requirements will be returned to the applicant by NCI program staff and will not undergo scientific peer review.
1. Eligibility
  (a) Institutional
  Applications may be submitted by domestic for-profit and non-profit organizations, either public or private, including universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators.
  (b) Minimum Research Base
  In order for a SPORE application to be accepted by NCI, the application must include four or more independent investigators who currently serve as principal investigators (or project leaders) on peer-reviewed research grants (e.g., R01, P01, U01, U10, ACS, DOD, or equivalent) directly related to the cancer(s) being investigated. The applicant is encouraged to provide a separate list of these grants or, alternatively, can highlight them on Other Support pages.
  (c) Cancer Patient Population
  Each SPORE must document access to a substantial patient population in the cancer-site focus of the application and provide reasonable assurance that the patients and tissues needed for translational research are readily available. If the appropriate patient population is not available to the applicant institution, a consortium agreement may be established with a different institution to provide adequate access to clinical specimens (tissue) and patients at another site.
  (d) Budget Limitation
  By NCI policy, all competing SPOREs are subject to both direct cost and total cost budget caps, which currently are $1.75 million and $2.75 million, respectively. In complying with the direct cost cap of $1.75 million, the indirect costs related to subcontracts to other institutions or organizations do not apply toward the direct cost cap. However, these consortium indirect costs must be included in the total cost which, overall, may not exceed the $2.75 million cap. Applications with requests exceeding these financial limits will be returned to the applicant without peer review. In non-competing years, applications can exceed these caps as a result of standard (yearly) cost-of-living increases or as a result of special supplements approved by the NCI. For more information about the cap in any given year, applicants must contact the Organ Systems Branch using the telephone number, fax number or e-mail address listed under INQUIRIES below.
2. Statement of Institutional Commitment
  An institution considering applying for a SPORE should demonstrate a commitment to the SPORE's stability and success by incorporating the SPORE high within its institutional priorities. The application must provide a statement of commitment that includes a plan addressing how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the SPORE research effort will be given a high priority within the institution relative to other research efforts. The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the SPORE Director, assignment of specialized research space, cost sharing of resources, or other ways proposed by the applicant institution. A letter from the Dean or Cancer Center Director should be attached confirming this commitment. In the case of a SPORE that involves a consortium arrangement between two or more institutions, the institution that submits the P50 application must receive a formal written agreement(s) from the other participant organization(s). This agreement should clearly delineate the institutional commitment of the participating organization(s) (in the ways outlined above) to the SPORE program.
3. Intellectual Property Rights
  The institution should provide a written assurance that it will protect the intellectual property rights of the SPORE investigators and their collaborators and under no circumstances engage in formal/legal agreements with commercial sources (e.g., pharmaceutical companies) that would compromise the ability of SPORE investigators to have unhampered access to institutional resources in SPORE-related research or participate fully in collaborations with any other researchers. The statement of commitment should also include a written assurance that in its interactions with commercial entities under sponsored research agreements, the SPORE will comply with the requirements of the Bayh-Dole Act and NIH funding agreements while upholding basic principles of academic freedom. Sponsored research agreements with commercial entities should be entered into by the SPORE only upon due consideration of the points outlined in "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts (Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp. 55674-55679)", a copy of which can be viewed at: http://ott.od.nih.gov/NewPages/text-com.htm. The statement of commitment should also include a written assurance that the SPORE will manage its interactions with third parties so that they do not restrict the SPORE's ability to receive and disseminate biomedical research materials from and to the scientific community. Likewise, letters should be supplied by any relevant third parties confirming their adherence to these policies.
4. Research Projects
  Research projects may be conducted solely through the parent institution, or through collaborative associations that have been developed or are planned with other SPOREs or with other investigators in the biomedical research community. However, all SPOREs must meet the following requirements:
  1. Each proposed research project must meet the definition of translational research as described in Section I.B above. Investigators who are not certain about whether their project fits this definition are advised to consult with NCI staff.
  2. Each proposed research project must be designed to test the relevance and/or potential importance of the research to human cancer within the five-year term of the grant (e.g., validation of a new screening mechanism or diagnostic test, early phase therapeutic trial, analysis of human tissues such as tumor or blood samples). Basic research projects, such as those employing animal models or cell lines, qualify as translational only if a human application is included in the specific aims of the research. A project(s) proposed in a competitive renewal application may focus solely upon the human application or laboratory effort if it marks the final stage of an ongoing translational SPORE study. Applicants are encouraged to contact the Organ Systems Branch (see INQUIRIES below) if they have any questions concerning this essential requirement.
  3. Each proposed research project must be led by co-(principal) investigators in biological science and applied sciences who commit adequate percent efforts and who use their combined conceptual and experimental skills in designing and implementing the project. It should be evident from this collaboration that translational research objectives will be accelerated such that it will be possible to test the relevance of the underlying hypotheses or to generate new hypotheses relevant to human disease. It is not necessary that the co-investigators commit equal effort to the project. There are NO exceptions to this requirement.
  4. At least ONE research project must focus on early detection, screening, prevention, and/or population science research. (Note that at least one scored project in this category will be required for award, see REVIEW CONSIDERATIONS, Section G.1. below.) If the application is funded, a project with this research focus must be maintained throughout the entire term of the grant.
  5. A minimum of four research projects are required representing a balance and diversity of translational research objectives (e.g., screening, prevention, diagnosis, treatment). Applications with a specific theme (e.g., gene therapy in prostate cancer) are discouraged. (Note that four projects scored by the peer review group will be required for award, see REVIEW CONSIDERATIONS, Sections G.1. and G.5. below.)
  6. A plan must be proposed for evaluating the scientific progress and translational potential of all projects and replacing them as necessary. During the period of award, replacement projects will be reviewed by the grantee institution and NCI program staff, but will not undergo additional peer review. Competing renewal applications will be evaluated based on their track record for fostering significant translational research during the prior grant period.
  7. Research projects involving HUMAN SUBJECTS must include women, children, and members of minority groups and their subpopulations unless a clear and compelling rationale establishes inclusion is inappropriate with respect to the health of the subjects, the purpose of the research, or another extenuating circumstance. Applicants are required to address this issue in developing a research design appropriate to the scientific objectives of their study. Instructions for responding to this issue are provided at: http://grants.nih.gov/grants/funding/phs398/section_3.html#humans and http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. Recruitment plans, as well as Gender and Minority Inclusion Reports must be included for each project/ resource that involves human subjects.
    
    Only early (Phase I and Phase II) clinical trials may be supported by the SPORE mechanism. A plan for a clinical trial must include provisions for rigorous data management, quality assurance, and safety monitoring. These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. Applicants should provide evidence that they will utilize Data and Safety Monitoring systems in place at their institution. A general description of the data and safety monitoring plans should be included in the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html). This description should explain the rules and procedures for detecting, monitoring, and reporting any adverse drug reaction or event during a clinical trial. A copy of the trial protocol, along with informed consent forms, are also required if the trial is already underway or is anticipated to begin soon after an award is made. If the trial will be performed during the latter part of the grant term, submission of these items to NCI program staff is required prior to the initiation of the trial.
    
    The NIH now also requires that all investigators proposing research involving human subjects are educated on the protection of human research participants. This policy was effective as of October 1, 2000 and was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000) which is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
5. Shared Resources (or Cores)
  1. Each SPORE must have a dedicated component for collecting and distributing human cancer site-specific tissue. The tissues may be frozen or archived paraffin blocks, slides, or fluids such as serum, plasma, urine, or sputum samples. This should be a true tissue resource that can be used to generate and test translational hypotheses, rather than a small collection of heterogeneous samples. The tissue core should also include the essential pathological, clinical and family history information needed for conducting a wide range of translational research. Appropriate informatics capability for tracking, as well as linkage to clinical and follow-up data sets, should be demonstrated.
    
    This resource should benefit the specific research activities of the SPORE, as well as the research activities of other scientists within and outside the parent institution who are concentrating on translational research issues. A plan must be proposed for prioritizing distribution of tissues to SPORE scientists and others based on the merit of translational cancer research projects.
  2. Additional shared resources (e.g., administrative, clinical, statistical, animal) may also be proposed that are supportive of one or more of the research projects of the SPORE.
6. Developmental Research Program
  Every SPORE must allocate a significant effort to support pilot projects that take maximum advantage of new research opportunities. Such projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE environment. The SPORE application should propose an institutional review process for funding pilot projects that generate feasibility data and have the most promising translational research potential. These funds are intended to remain flexible and to support studies of a limited duration, e.g., two years or less. The expectation is that successful feasibility studies will replace full projects that are not progressing satisfactorily with regard to translational research objectives within the SPORE (see above). New applicants may supply a short description (1-2 page(s) maximum) of eligible projects as examples. Renewal applicants should supply their track record of funding pilot projects, ongoing pilot projects, and short descriptions of other potentially eligible projects.
  
  A Developmental Research Program, as a required element of a SPORE, must be maintained throughout the entire term of the grant.
7. Career Development Program
  The SPORE must demonstrate a consistent and significant commitment to a career development program in translational cancer research. This may focus on advanced post-doctoral candidates, junior faculty, or established investigators who wish to develop or refocus their careers on translational research. SPORE career development programs are not intended for predoctoral candidates.
  
  An appropriate portion of the total SPORE budget should be dedicated to this program and support the salary and research costs of candidates with outstanding potential. Each candidate should have a mentor(s) and devote a significant percentage of his/her effort to translational research. The description of this program should include the policies, criteria, and processes for selecting candidates, including special efforts to recruit qualified women and minorities. The plan should include the number and types of positions (e.g., advanced post-docs, junior faculty, established investigators) that will be made available, the criteria for eligibility and selection of candidates, and a description of the selection process. New applicants should provide a list and short description of potential candidates, as well as the names and research activities of mentors. Renewal applicants should provide this in addition to the track record of candidates supported on the SPORE.
  
  A Career Development Program, as a required element of a SPORE, must be maintained throughout the entire term of the grant.
8. Annual SPORE Workshop
  SPORE investigators will be expected to participate in an annual workshop organized by the Organ Systems Branch of the NCI to share positive and negative results with other SPOREs, share materials, assess progress, identify new research opportunities, as well as establish interactions, research priorities, and collaborations that will maximize the impact of the research on reducing incidence and mortality, and improving survival. Travel funds for the Principal Investigator and selected SPORE investigators and collaborators may be budgeted for this purpose. In conjunction with the workshop, SPORE Directors will be required to attend an administrative and planning meeting with program staff from the NCI.
9. Other Provisions
  If a SPORE application originates from an institution that is supported by an NCI Cancer Center Grant (P30), the following items should also be addressed (generally within the Program Description).
  1. Once a SPORE is funded, the Principal Investigator of the SPORE should become a senior leader in the Cancer Center. The Principal Investigator of the SPORE may or may not be the Cancer Center Director.
  2. Lines of authority should be clearly indicated such that the SPORE is an integral part of the Cancer Center but does not interfere with the P30 chain of authority. A letter of commitment which delineates these organizational relationships is required. This letter must be signed by the proposed Principal Investigator of the SPORE, as well as the Cancer Center Director.
  3. The applicant should discuss how the SPORE will interact synergistically with existing P30 programs in order to maximize both SPORE and Cancer Center research objectives. While the SPORE is expected to become an integral element within the NCI-designated Cancer Center, a distinct institutional commitment to the SPORE must still be maintained throughout the term of the SPORE grant (see Section E.2. above).
  4. The resources (or cores) within the SPORE should not duplicate any available facility already in place and supported by another granting mechanism (e.g., P30, P01, U01, U10, DOD, etc.). Applicants can, however, use SPORE funds to augment pre-existing Cancer Center resources in order to direct these activities towards more effectively fulfilling the requirements of the SPORE. This is especially true of the SPORE tissue resource, which should be designed to prioritize the needs of SPORE investigators over those of others. The SPORE should also utilize the IRB, Data and Safety Monitoring Board(s), as well as clinical resources available throughout the Cancer Center whenever possible.
Submission Requirements and Receipt Dates
1. Pre-application Consultation (Strongly Recommended)
  NCI program staff strongly encourages each prospective applicant to schedule a pre-application consultation. The consultation should be scheduled four to six months in advance of the due date for submission and is intended to help the applicant (along with one or more of his/her intended co-investigators) understand the SPORE Program and discuss strategies for preparing a competitive application. NCI staff will clarify the intent of the guidelines, discuss funding trends, discuss potential alternative SPORE organizational structures and allowable resources, and describe the peer-review process. The applicant can define which issues would be most helpful to discuss and then work with NCI program staff to decide what information is most appropriate to provide. The following are examples of items that help NCI program staff understand the plans of applicants:
  - A brief description of the background and proposed responsibilities of the SPORE Director and key senior leaders of the SPORE.
  - A diagram showing the proposed reporting, programmatic, and advisory structure of the SPORE and how it relates to the structure of the institution as a whole.
  - A brief description of the proposed translational research projects, along with their specific aims and the names of project leaders.
  - Estimated budgets for each component (i.e., full projects, resources, developmental/career programs) of the anticipated SPORE application.
  - A list of active peer-reviewed research grants, cooperative agreements, and contracts that form the research base of the scientific leaders of the SPORE.
2. Letter of Intent
  Although it is not required and does not enter into the review of an application, all prospective applicants are requested to submit a letter of intent at least 60 days prior to the receipt date for the application. The letter of intent should include a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. This letter allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Furthermore, NCI staff can make sure applicants are fully aware of all applicable NIH and NCI policies, meet eligibility requirements and understand the peer review process before the application is submitted.
  The letter of intent should to be sent to the following address:
3. Application Procedures
  The NIH application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application forms and guidelines are available through: http://grants.nih.gov/grants/funding/phs398/phs398.html, most institutional offices of sponsored research, or from:
  Copies of the SPORE guidelines and program announcements are available at the following URL addresses, respectively: http://spores.nci.nih.gov and http://grants.nih.gov/grants/guide/index.html. Instructions in these documents must be followed in preparing a SPORE application. On line 2 of the face page of the application form, the applicant should provide the Program Announcement (PA) number, the title "SPORE in (Organ) Cancer", and check the YES box.
  At the time of submission, the original signed application, including the checklist, should be sent along with three copies (without appendices) to:
  Two additional copies of the application and five copies of any appendices must also be sent to:
  The copies to the Center for Scientific Review (CSR) and the Division of Extramural Activities (DEA) should be sent at the same time to assure that the NCI will be able to review the application along with others submitted for the same receipt date. The applicant is encouraged to keep documentation of their mailing date(s) rather than contact the CSR or DEA for confirmation of receipt. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applications must meet all eligibility requirements as described above and must address all programmatic requirements (see ELIGIBILITY AND REQUIRED COMPONENTS, above) in these guidelines.
4. Application Receipt Dates
  Due to the logistical problems that would be created by simultaneously accepting and reviewing grant applications for all cancer sites, the NCI has implemented a transition plan that will move the program towards one receipt date per organ site per year by the year 2005.
  Receipt dates for cancer sites will be announced each year with a formal program announcement in the NIH Guide http://grants.nih.gov/grants/guide/index.html). The tentative receipt dates for organ sites during this transition period are as follows:
5. Inclusion of Women, Minorities, and Children in Research Involving Human Subjects
  All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
  It is also the policy of the NIH to include children (i.e., individuals under the age of 21) in all human subjects research conducted or supported by the NIH, unless there are scientific or ethical reasons to exclude them. This policy applies to all initial (Type 1) applications submitted for receipt after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
  As part of the scientific and technical merit evaluation of the research plan, reviewers are instructed to consider the adequacy of the plan for including women, minorities, and children. Omission of this information (including reasons for exclusion) can have a negative impact on the priority score of a specific project and/or the overall application. In preparing these sections of the application, investigators are encouraged to follow the additional instructions provided under Section E.4.f. above.
6. URLS in NIH Grant Applications or Appendices
  All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site.
7. Required Education in the Protection of Human Research Participants
  Investigators proposing research involving human subjects are now required to demonstrate that they have been trained in the protection of human research participants according to the policy published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
8. The Office of Management (OMB) Circular A-110
  The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA (PA) in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Review Considerations

Review Policies
Upon receipt of an application, the Scientific Review Administrator (SRA) in the NCI Division of Extramural Activities (DEA) reviews it for completeness and conformance to NIH policies. The application is then evaluated for responsiveness to all required components in the PA by OSB program staff. Applications that are incomplete or are non-responsive to the NCI SPORE Program will be returned to the applicant without further consideration (See section E above).
Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute and informed of the review criteria provided below. While all eligible applications will receive a written critique, some may be removed from further consideration by the peer review group in the initial stages of the merit review process. In these instances, only applications deemed to have the highest scientific merit will be discussed further by the review panel. In addition, if a required component(s) of an otherwise meritorious SPORE application is of such low merit that it is not recommended for further consideration (NRFC) by the peer review committee, the entire application will be unscored. See Section I.E. of this document for a description of the required components of a SPORE application. Applications that receive a full review are assigned a priority score and receive a second level review by the National Cancer Advisory Board (NCAB).
Application Receipt and Referral
SPORE (P50) applications, like all other PHS applications, are received and initially processed by the NIH Center for Scientific Review (CSR). Following the current NCI referral guidelines, the application is assigned to NCI and subsequently to the Organ Systems Branch and SPORE program area. An SRA in the Grants Review Branch in the NCI Division of Extramural Activities will be assigned to manage the review.
After application submission, all correspondence should be directed to the SRA. Applicants are expected to submit complete applications by the specified receipt dates. The decision on whether to accept additional supplementary documentation is that of the SRA.
Review Procedures
As the manager of the review process, the SRA serves as the resource for both applicants and reviewers with respect to NIH review policies, guidelines, rules, regulations, options available, procedures, etc. He or she ensures that the review is conducted in accordance with NIH and NCI policies. The NCI Program Director serves as a resource, as needed, concerning the history, intent and development of the program, changes in program direction, objectives and any other relevant programmatic matters.
The scientific merit of a SPORE application is assessed by the peer review committee. Review of a SPORE application will include participation of senior scientists with review experience, a broad perspective on cancer research, and a wide variety of expertise. Breadth is a necessary component of the review committee. Patient advocates also provide important points of view in regard to translational research conducted by SPOREs and therefore will also serve as members of this review committee. Applicants should take into account the fact that their application is reviewed by multiple individuals. Any piece of information that is critical to a particular project, resource, or program should be presented within the section designated for that activity (and not just within the overall "Program Description", for example).
Following assignment of a priority score by the review committee, action by the NCAB completes the peer-review process.

Review Criteria
The evaluation of applications is based on the following:

(a) Full Projects
Within the SPORE concept of translational research (see definition in Section I.B. above), reviewers will evaluate each research project using the five review criteria and additional factors noted below. Each criterion will be considered by the reviewers in assigning the overall merit score of the project, although a project does not need to be strong in all criteria in order to be viewed as meritorious.

(a.1) Significance
The importance of the translational research objective to human cancer and its likelihood of completion within the maximum five year project period. For competitive renewals, completed and ongoing projects will be critically evaluated for their scientific progress and success in adhering to the five-year project period.

(a.2) Approach
The adequacy of the experimental design and methods to achieve the research objectives, as well as clear evidence of co-leadership by a scientist with a basic biological background, basic and/or applied scientist with a clinical research or population science research background in the conception, design, and proposed implementation of the project. Rationale for changing scientific direction and/or approach will also be evaluated for competitive renewals.

(a.3) Innovation
Originality and novelty of experimental concept, design, and/or approaches as they relate to the SPORE definition of translational research (See Section I.B.).

(a.4) Investigators
The qualifications of the basic biological and more applied co-investigators to conduct the proposed research and the appropriateness of the time commitments of each co-investigator to conduct the project.

(a.5) Environment
The scientific environment in which the translational research work will be done and the unique features, if any, of the environment to support the proposed work.

The following factors are also evaluated on each research project:

Evidence of the full protection of human subjects in clinical/epidemiological research components and appropriate mechanisms for the rigorous management and quality control of research data involving human subjects;
Adequacy of the plans to include both genders, minorities and their subgroups, and children, as appropriate, to meet the scientific goals of the research.
Appropriateness of the budget to achieve the stated research objectives.

(b) Shared Resources (Cores)

(b.1) Tumor Bank/Tissue Resource

Adequacy of the proposed plan and/or track record to develop and maintain a human cancer site-specific tissue resource, store the tissue, link the tissue with appropriate pathological, clinical, and family history data that maximize their potential use in translational research.
Adequacy of the proposed plan and/or track record to prioritize the distribution of tissues within and outside the SPORE.
Evidence of experienced and available personnel dedicated to the activities of tissue collection, quality control of tissue specimens, tissue storage, tissue distribution, collection of initial and follow-up clinical information, data entry, and maintenance of database and computer networks.
When appropriate, adequacy of the proposed plan/track record to augment and/or complement any existing tissue resource supported by a Cancer Center Support Grant (P30) to avoid duplication and maximize productivity.
Adequacy of the proposed plan and/or track record to obtain informed written consent for all prospectively collected tissues and protect confidentiality.
Appropriateness of the budget to conduct and integrate tissue banking activities.

(b.2) Other Resources
Degree to which plans and/or track record indicate that shared resources (will) effectively and efficiently support the research of the SPORE in a manner that can not be supported through other available (institutional or outside) resources.

When appropriate, adequacy of the proposed plan/track record to augment and/or complement an existing shared resource supported by an NCI Cancer Center Support Grant (P30).
Demonstration that the resource is essential to the success of the SPORE.
Adequacy of qualifications and performance (if applicable) of resource directors.
Appropriateness of requested budgets to conduct each resource operation.

(c) Developmental Research Program
(c.1)
Adequacy of the process and/or track record for attracting new ideas and pilot studies within and outside of the SPORE institution.

(c.2)
Adequacy of the proposed process and/or track record for continuously reviewing and funding a spectrum of pilot projects (e.g., research, technology development, resources) based on their relevance to translational research and impact on human cancer. For competitive renewals, this program should also be evaluated by the SPORE's ability to promote outstanding translational pilot projects to full projects and/or demonstrate the successful competition of these projects for outside funds.

(c.3)
Appropriateness of the budget relative to the needs and demonstrated capabilities of the SPORE.

(d) Career Development Program

(d.1)

Adequacy of the plan, in general, to sustain a significant activity for career development of translational research scientists.

(d.2)
Adequacy of the process and/or track record for selecting candidates for independent careers in translational cancer research.

(d.3)
Adequacy of the procedures and/or track record to seek out and include qualified minorities and women.

(d.4)
If applicable, current status and research activities of individuals who have been supported by the career development program.

(d.5)
Appropriateness of the budget (whether derived entirely from the SPORE or a combination of sources) relative to the proposed plans for sustaining a significant effort in career development.

(e) Overall Program Organization and Capability
(e.1)

Scientific qualifications and involvement of the SPORE Principal Investigator as well as his/her demonstrated scientific and administrative leadership capabilities and time commitment.

(e.2)

Adequacy of the planning and evaluation process to include: determining translational research productivity of existing projects and resources; discontinuing activities of low productivity; initiating new activities in response to important translational research opportunities; establishing collaborations; and utilizing the advice of external advisors.

(e.3)

Adequacy of access to patients and populations for conducting current and projected therapeutic, prevention, detection and control research.

(e.4)

A balance and diversity of research activities within a minimum of four scored projects, including at least one devoted to early detection, screening, prevention, and/or population science.

(e.5)

Effectiveness of and/or plans for promoting interdisciplinary scientific interactions.

(e.6)

Effectiveness of and/or plans for integrating SPORE research and resources with existing Cancer Center/Institutional programs (e.g., use of clinical data and safety management systems, biostatistical cores, etc.).

(e.7)

Adequacy of tangible institutional commitments that will enable and facilitate the research objectives of the SPORE (e.g., special facilities, recruitments, discretionary resources such as dollars and space).

(e.8)

Degree to which the organization and leadership of the SPORE promote and facilitate scientific interactions between projects, pilot projects, etc., and effective use of the SPORE infrastructure (e.g., tissue bank, other shared resources) in the conduct of research.

(e.9)

Written assurance that SPORE interactions with commercial entities will uphold the principles of academic freedom, including the ability of SPORE investigators to collaborate freely and to send and receive biomedical research materials without restriction to other scientific researchers.

(e.10)
Facilitation of technology transfer; management of the intellectual property rights of the SPORE under the requirements of the Bayh-Dole Act and NIH funding agreements.

(f) Interactions with Other SPOREs
(f.1)

Adequacy of plans (new applications) or progress (competing renewal applications) to promote and maintain communication and integration of scientific projects of mutual interest with other SPOREs; examples include the development of core resources that serve either the same organ site or multiple organ sites, as well as clinical or research activities performed in a multi-institutional setting.

(f.2)

Willingness to interact with other SPOREs and with the NCI in sharing information and participating in committees to assess current scientific issues, research activities, and priorities.

Overall Evaluation and Scoring of Applications
A single numerical priority score will be assigned to the SPORE application as a whole after discussing all of the review elements listed above. The score will be based on the overall quality of the research projects (using the SPORE definition of translational research in Section I.B.) and career development and developmental research programs, the overall effectiveness and adequacy of shared resources, the overall program organization and capability, and the plans for and productivity of interactions with other SPOREs. Although primary emphasis will be placed on scientific merit and progress where applicable (competing renewal applications), significant consideration will also be given to interdisciplinary interactions, potential for impacting on the disease, Inter-SPORE collaborations and institutional commitment.
The overall score will be weighted as follows:
If a required component(s) of an otherwise meritorious SPORE application is of such low merit that it is not recommended for further consideration (NRFC) by the peer review committee, the entire application will also receive a NRFC.
Summary Statements
The findings and recommendations of the reviewers are summarized in a written report (i.e., Summary Statement) which conveys the evaluation of the P50 application. This Summary Statement is transmitted to the NCAB for second level review, to the NCI official file and to the appropriate NCI staff. NCI program staff will automatically send a copy to the principal investigator as soon as the final document is available.
Award
Final funding decisions are made by NCI Executive Committee (EC) based on overall priority scores of the applications as determined by peer review, recommendations by the NCAB, the availability of funds, and NCI research priorities during each fiscal year.
The EC may consider funding a P50 application as a P20 planning grant. Applications considered for P20 awards will be funded on the basis of their scientific merit and NCI programmatic priorities.
The award and administration of the P50 and P20 grants are subject to the same policies and procedures as other research grants. These policies and cost principles are set forth in the current NIH Grants Policy Statement, other NIH and NCI issuances and Federal legislation and regulations.

Inquiries

For further clarification of the different topics contained in the present guidelines, individuals may contact the Organ Systems Branch by e-mail (nciosb-r@mail.nih.gov), phone (301-496-8528), or fax (301-402-5319).

SECTION II. SPECIAL INSTRUCTIONS FOR PREPARING A COMPETING SPORE GRANT APPLICATION

General Information

General instructions for the preparation of NIH grant applications are contained in the standard NIH grant application kit (PHS Form 398, revised April 1998) which should be available at an applicant's institutional business office. Even though the application kit is intended primarily for a single research project grant (i.e. R01), many of the general instructions and forms also apply to SPORE grant applications. However, as outlined in Section I, SPORE grants have unique requirements and review criteria. Accordingly, the special instructions in this document were prepared for use along with the PHS Form 398 grant application kit.
Detailed Directions
1. Face Page
  The face page is the same as the face page (form page AA) in the PHS 398 kit. In item 1, enter the title "SPORE in (Organ-Specific) Cancer". In item 2, insert the PA number, and enter the title "Specialized Program of Research Excellence". In item 3, indicate the name, degree, and position (or equivalent) title of the SPORE Principal Investigator. Complete the rest of the page according to the instructions in the application kit, including the signature of the appropriate institution official(s).
2. Description, Performance Sites, and Key Personnel (Page 2)
  Page 2 is the same as page 2 in the PHS 398 application kit. Provide a brief description of the proposed SPORE in the space provided, specifically addressing each project and proposed resource core. Fill in all the performance sites and all key professional personnel including all project and core leaders and key personnel of the Developmental Research and Career Development Programs, using continuation pages as required.
3. Table of Contents (Page 3)
  Instead of using form page 3 in the PHS 398 application kit, prepare a Table of Contents that identifies by page number all major parts of the SPORE application so that they can be readily located. When listing individual projects and core components, identify each by a project or core number, title and responsible investigator(s) in the order in which they appear in the application.
  It is recommended that all applicants follow a format similar to that outlined below:
  1. Face Page
  2. Description, Performance Sites, Key Personnel (PHS 398 Form Page 2)
  3. Table of Contents (PHS 398 Form Page 3)
  4. Initial Budget (PHS 398 Form Page 4; see item 4 below)
  5. Summary Budget (PHS 398 Form Page 5; see item 5 below)
  6. Biographical Sketches (PHS Form Page 6; see item 6 below)
  7. Other Support (see item 7 below)
  8. Resources (see item 8 below)
  9. Eligibility Statement (see item 9 below)
  10. Program Description (see item 10 below)
    1. Introduction
    2. Institutional Commitment
    3. Scientific and Administrative Leadership
    4. Relationship to Cancer Center
    5. Scientific Integration - Interactions and Collaborations
    6. Cancer Patient Population
    7. Translational Research Objectives
    8. Planning and Evaluation Activities
  11. Research Projects (Minimum of four projects required; see item 11 below)
    1. For competing renewals, describe, outline the scientific accomplishments and discuss the potential impact on the disease for each project completed in the last grant period. Limit this to two narrative pages plus publications for each project.
    2. Project 1
      1. Title Page with Co-(Principal) Investigators
      2. Abstract Page
      3. Budget/Budget Justification Pages
      4. Research Proposal (If an ongoing project, discuss scientific progress and adhere to the original five-year time frame)
      5. Human Subjects and Vertebrate Animals
    3. Project 2
      1. Title Page with Co-(Principal) Investigators
      2. Abstract Page
      3. Budget/Budget Justification Pages
      4. Research Proposal (If an ongoing project, discuss scientific progress and adhere to the original five-year time frame)
      5. Human Subjects and Vertebrate Animals etc.
  12. Core Resources (Tissue Core required; see item 12 below)
    1. Core 1
      1. Title Page with Director(s)/Leader(s)
      2. Abstract Page
      3. Budget/Budget Justifications
      4. Plan/Interactions/Progress (for competing renewals)
      5. Human Subjects and Vertebrate Animals
    2. Core 2
      1. Title Page with Director(s)/Leader(s)
      2. Abstract Page
      3. Budget/Budget Justifications
      4. Plan/Interactions/Progress (for competing renewals)
      5. Human Subjects and Vertebrate Animals etc.
  13. Developmental Research Program (see item 13 below)
    1. Title Page with Director(s)/Leader(s)
    2. Budget/Budget Justification Pages
    3. Plan/Examples
    4. For competing renewals describe each project funded during the last grant period and the outcome of each project relative to the SPORE objectives.
  14. Career Development Program (see item 14 below)
    1. Title Page with Director(s)/Leader(s)
    2. Budget/Budget Justification Pages
    3. Plan/Examples
    4. For competing renewals, denote individuals supported during the last grant period, their scientific accomplishments while supported by the SPORE, and how SPORE support has advanced their translational research careers.
  15. Checklist (see item 15 below)
  16. Appendix Material (see item 16 below)
4. Summary Program Budget for the Initial Budget Period
  Use form page 4 in the PHS 398 application kit to present the summary budget for the first year. For each category, show separately the total amounts requested for each research project and core.
  If the grant application includes research activities that involve institutions other than the applicant organization, the proposed program represents a consortium effort. It is essential to explain the programmatic, fiscal, and administrative arrangements for such activities. These matters should be discussed in general terms in the program introduction, and more specifically within descriptions for pertinent projects. Include in the designated blocks on this page the total (direct and indirect) costs associated with such third party participation. The published policy governing consortia should be available in the business office of the grantee institution.
5. Summary Program Budget for Entire Project Period
  Use form page 5 in the PHS 398 application kit to show the total SPORE budget requested for each of the five years. Justifications for increases in succeeding years should not be included here; they should be delineated in the detailed budgets for individual projects (as described below in item 11). Note that current NIH practice limits overall budget escalation per year to 3% cost-of- living. Also note that NCI policy for SPORE grants establishes an annual direct cost cap of $1.75 million and maximum annual total cost cap of $2.75 million for new and competing applications. In complying with the direct cost cap of $1.75 million, the indirect costs related to subcontracts to other institutions or organizations do not apply toward the direct cost cap. However, these consortium indirect costs must be included in the total costs which, overall, may not exceed the $2.75 million cap. In non-competing years, applications can exceed these caps as a result of the standard cost-of-living increases or special supplements approved by the NCI.
6. Biographical Sketches
  Prepare biographical sketches as described in the PHS 398 application kit. Begin with the Principal Investigator/SPORE Director and then proceed in alphabetical order. Biographical sketches are required for all professional personnel participating in the individual SPORE projects and core(s). The "Biographical Sketch" form is provided as form page 6 in the PHS 398 application kit.
7. Summary of Other Support
  Information on all current and pending research support of all personnel should be presented in this section. Please indicate by an asterisk, research support that overlaps with projects proposed in the subject P50 application. Beginning with principal investigator/program director and in alphabetical order thereafter, list in two separate sections for each investigator: (1) Current Support and (2) Applications Pending Review and/or Funding. After listing all support, summarize for each individual any potential overlap with active or pending projects and this application in terms of the science, budget, or committed effort and describe modifications to be made if an award is received. Information contained in the Other Support section should use the format shown on page 7-GG of the PHS 398 application kit.
  In addition, if any of the projects in (1) or (2) above are to be integrated into the SPORE with modifications, briefly explain how this integration will be accomplished.
8. Resources
  Complete form page 8 of PHS 398 application kit, as instructed. If applicable, additional Resource pages should be provided in consortia projects or cores. An extensive discussion of the institution's commitment to the SPORE is also required in item 10b below.
9. Eligibility Statement
  In considerable detail, specifically address how this application meets the eligibility requirements under ELIGIBILITY AND REQUIRED COMPONENTS, Section I.E.1." above.
10. Program Description
11. Translational Research Projects
  As previously described, for the purposes of this program, the NCI has defined translational research as follows: "Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans AND/OR determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer". The term "interventions" is used in its broadest sense to include molecular assays, imaging techniques, drugs, biologicals and/or other methodologies that are relevant to the prevention, early detection, diagnosis, prognosis or treatment of cancer. Translational research in SPOREs is always founded on and directly connected to some aspect of human biology and may encompass any form of cellular, molecular, structural, biochemical, genetic, or other appropriate experimental approach.
  SPOREs conduct early-stage interventions to establish the feasibility or proof of principle of specific approaches in cancer. All research projects whose goal is the development and testing of an intervention are expected to reach the feasibility testing stage in humans within the anticipated five-year period of grant support. Similarly, studies that seek to determine the biological basis for an observation in human cancer should do so within five years. SPOREs are not the place for definitive validation of new interventions, which are supported by other programs in several divisions of the NCI.
  Questions regarding the definition of translational research and its applicability to specific research projects should be directed to OSB program staff (see INQUIRIES, Section I.H. above).
  For each research project provide the following as noted below. Page limitations specified for individual (R01) grant applications in the PHS 398 application kit must be followed for individual project and core unit research plans. Unnecessarily long, wordy or confusing presentations are usually perceived as indicators of premature or poorly planned research.
  1. A title page with a project number, a title for the project and the co-principal investigators on a plain piece of paper.
  2. An "Abstract of the Research Plan" using page 2 of the PHS 398 application kit. The top section should contain a succinct summary of the research project. The bottom section should include performance sites and all key professional personnel as instructed.
  3. Budget Pages
    The detailed budget for the first 12 months and the overall budgets for each succeeding year for each research project should be presented using the PHS 398 application, form pages 4 and 5 Directions for completing these are on pages 11-13 of the instructions in the PHS 398 application kit. For each category or individual listed on form page 4, provide a rationale in the budget justification.
  4. Research Plan
    Following the budget pages, use continuation pages to address items 9a through 9i as explained on pages 14-19 of the PHS 398 application kit. For renewal of ongoing projects, delineate the scientific progress over the past term of the grant and, if applicable, why the project has not completed its proposed objectives in the five year period.
    Page limitations are the same as those delineated in the PHS 398 application kit; no more than 25 pages should be used for sections a-d of the Research Plan for each project proposed within the SPORE application. The 25-page limit also applies to all other self-contained components of the application, e.g., each Shared Core Resource, the Developmental Research Program, and the Career Development Program.
  5. Human Subjects
    For projects involving human subjects, applicants are required to address the six points on pages 17-18 of the PHS 398 instructions. The six points are as follows:
    1. Provide a detailed description of the proposed involvement of human subjects in the work previously outlined in the Research Design and Methods section. Describe the characteristics of the subject population, including their anticipated number, age, range and health status. Identify the criteria for inclusion or exclusion of any subpopulation. Explain the rationale for the involvement of special classes of subjects, such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable.
    2. Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data. Indicate whether the material or data will be obtained specifically for research purposes or whether use will be made of existing specimens, records, or data.
    3. Describe plans for the recruitment of subjects and the consent procedures to be followed. Include the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. State if the Institutional Review Board (IRB) has authorized a modification or waiver of the elements of consent or the requirement for documentation of consent. The informed consent form, which must have IRB approval, should be submitted to the PHS only if requested.
    4. Describe potential risks (physical, psychological, social, legal or other) and assess their likelihood and seriousness. Where appropriate, describe alternative treatments and procedures that might be advantageous to the subjects.
    5. Describe the procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Also where appropriate, describe the provisions for monitoring the data collected to ensure the safety of subjects.
    6. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the knowledge that may reasonably be expected to result.
    Plans for the recruitment of women, children, and members of minority groups and subpopulations into clinical studies must also be stated in this section. A completed table, formatted like the one shown on page 30 of the PHS 398 instructions must be included along with a description of the proposed subject population in terms of gender and racial/ethnic groups.
  6. Vertebrate Animals
    If applicable, provide a brief description of any animal protocol, along with an IACUC approval number in this section. The five points for vertebrate animals listed below (as well as on page 18 of the PHS 398 instructions) should be addressed:
    1. Provide a detailed description of the proposed use of the animals in the work outlined in the Research Design and Methods section. Identify the species, strains, ages, sex and numbers of animals to be used in the proposed work.
    2. Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.
    3. Provide information on the veterinary care of the animals involved.
    4. Describe the procedures for ensuring that discomfort, distress, pain and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize the discomfort, distress, pain, and injury.
    5. Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.
12. Core Resources
  Core resources should not duplicate products or services that are fundamentally available through any other mechanism (including a P30 and P01) or national resources supported by the NCI. SPORE resources may, however, be used to augment an existing P30 resource to enhance its capacity to serve SPORE research objectives. Cores can be used for a small administrative component or for scientific resources that clearly enhance the specialized research of the SPORE. Cores in the latter category should serve at least one full project. For each Core Resource, whether administrative or scientific, provide the following information:
13. Developmental Research Program
  This program should primarily be used to promote the exploration of innovative ideas through the funding of pilot projects. It can, however, also be used to initiate a new shared resource, establish short-term collaborations, and/or contract services required by the SPORE. This required component of the SPORE must be maintained for the duration of the grant period. This section of the application should include:
14. Career Development Program
  This is a special fund available in a SPORE that can be used to prepare new investigators or established investigators for careers in translational cancer research. This section of the application should include:
15. Checklist
  Complete the checklist as required in the PHS 398 application kit.
16. Appendix Material
  The application should be a complete document that includes all essential information necessary for its evaluation. Additional appropriate material may be submitted as appendices. There is no page limitation on appendices. However, appendices should not be used to bypass page limitations in the application because only selected reviewers will receive copies of the appendices. Follow the guidance in the PHS 398 application kit on page 19 regarding appendices, in particular noting what types of material may be included in an appendix.

SECTION III. SUPPLEMENTAL GUIDELINES FOR PREPARING A NONCOMPETING CONTINUATION SPORE APPLICATION

Introduction
These instructions are supplemental to those provided with the Form PHS 2590 (rev. 4/98), "Application for Continuation of a Grant," which is required each year in order to receive continuing support. In general, you should follow the "Information and Instructions for Using Form PHS 2590 to Apply for Continuation of a Grant Award." To avoid a gap in funding, non-competing continuation applications should be received 60 days prior to the anniversary date of the award. Please note that non-competing SPORE applications are not eligible for the streamlined non-competing award process (SNAP). Additional guidance important in the preparation of a SPORE continuation application is provided below.
General Issues
The NCI advocates flexibility and innovation in the use of SPORE funds to achieve translational research objectives and will administer these grants in that spirit. Nevertheless it is important to highlight and explain changes in the component budgets that differ significantly from the approved peer-reviewed budget levels of the original competing application. Areas requiring explanation and justification are as follows:
1. Any proposed increase or decrease in the level of effort of key personnel.
2. Substitution, addition, or deletion of key personnel (e.g., project leader, co-leader, resource director).
3. Redistribution of dollars among budget components (NOTE: this is encouraged in a SPORE when it is done to place greater emphasis on more promising translational research activities).
4. New research activities not included in the competing application and not peer reviewed (NOTE: this is encouraged, especially in the use of developmental funds, to pursue the feasibility of new hypotheses of potential importance to translational research).
Progress Report Summary
The Progress Report Summary portion of the PHS 2590 application (pages 7-9) should be used for each full and developmental project within the SPORE. Applications should also include the following:
1. Scientific Achievement of the SPORE Program
  Describe the single most significant translational research achievement in the last year of support. Indicate the project, the achievement, and its potential impact on human cancer in one or two paragraphs.
2. Director's Overview
  This is an important section in which the Director describes how the SPORE program is functioning in special ways to achieve translational research objectives. In this section address the following issues:
  1. The levels at which applied researchers (e.g., clinical researchers, prevention and control researchers) interact with basic investigators in the design and implementation of research that is most likely to have an impact on human cancer (i.e., reducing incidence and mortality).
  2. The different ways in which the members of the SPORE team are working together and exchanging ideas.
  3. The specific research efforts that appear to be the most, as well as least, promising in achieving a translational research objective.
  4. New ideas for translational research that have been generated by the SPORE.
  5. New priorities affecting the distribution of SPORE research funds based on the research progress of existing projects and results obtained from the use of developmental funds.
  6. Important collaborative efforts established within and outside the SPORE institution, through use of developmental or supplemental funds, that increase the exploration of new translational research opportunities.
  7. By-products that have emerged from SPORE scientists, the SPORE environment and/or SPORE collaborative studies that have resulted in the submission of grant applications (e.g., R01s) which are likely to advance fundamental studies in this cancer site. Please list in tabular form grant applications that have been submitted, where and when submitted, and whether pending, funded or not funded.
  8. Formal Inter-SPORE collaborative research activities that have been initiated and/or completed.
  9. Special efforts to recognize unique research opportunities based on incidence and mortality rates in the community/region of the SPORE and/or to enhance the research capability of the SPORE through interactions with individuals, organizations, and institutions within the community.
  In all of the above, the intent should be to explain how the team of SPORE scientists at the basic and applied levels are pursuing research objectives using integrated, innovative, and flexible strategies and are maximizing the unique capabilities of SPORE support in achieving translational research objectives.
3. Research Projects
  Adhering to the instructions provided in the PHS 2590 packet, please describe the following:
  1. Specific Aims (no more that 500 words)
    Briefly describe the specific aims of the project as actually funded and how basic/clinical interactions have been employed in the design, implementation, and interpretation of experiments. Provide a short rationale for any changes in specific aims that have occurred over the past year.
  2. Studies and Results (no more than 750 words)
    For the past year, describe positive or negative results associated with each specific aim that are important to the underlying hypothesis. For those projects that involve clinical trials, briefly describe the status of each trial.
  3. Significance
    Explain in lay terms the importance and intent of the research in terms of translational research objectives that may impact on the disease in a reasonable time span.
  4. Plans
    Summarize plans for the next year to pursue existing specific aims and/or new or modified aims that may have a greater impact on the translational research objectives of the SPORE.
  5. Publications
    Append a list of published, submitted, or accepted manuscripts from the past year that pertain to this grant (i.e., those that acknowledge support from this grant). Provide one copy of each new manuscript.
  6. Project-Generated Resources
    If the research supported by this grant resulted in data, research materials (e.g., cell lines, DNA probes, animal models), protocols, software, or other information available to be shared with other investigators, describe the resource(s) and how it may be accessed.
  All projects involving human subjects or tissue resources should include status of patient/specimen accrual and recruitment of gender and minorities where applicable. An updated Gender and Minority Inclusion Table is required each year for each individual project. This table is provided at the bottom of form page 5 of the PHS 2590 application. Final assessment of closed or completed studies and pertinent publications and reports should also be included. A protocol and IRB approval must be on file with the NCI prior to the initiation of any new clinical trials.
4. Resources
  Describe progress in establishing and maintaining the high-quality operation of each resource outlined in the original competitive application. Discuss any structural, organizational, logistical, or administrative changes in the resource; problems that have developed in the operation of the resource, as well as use of the resource by members of the SPORE and by outside investigators where appropriate.
5. Developmental Funds
  In reporting on the use of developmental funds, describe the following:
  1. How the funds are being used in a flexible manner to explore new research opportunities and how the SPORE sets priorities in the use of developmental funds.
  2. The translational research objectives of each current pilot project being explored with developmental funds.
  3. The positive and/or negative findings for each project during the past year. A final report is required on projects whose SPORE funding ended during the past year. Brief descriptions of newly initiated projects should also be supplied.
  4. Projects in which developmental funds have stimulated new collaborative interactions with scientists within or outside the SPORE institution.
  5. Pilot projects that have become full translational research projects within the SPORE or have resulted in research grant application of a more fundamental nature relevant to the cancer site (e.g., R01s).
6. Career Funds
  Briefly describe how each individual, whether recruited from within or outside the institution and supported from SPORE resources, is being prepared to pursue a career in translational research. As appropriate, indicate the current research activities of individuals who received career support from the SPORE program in the past.
7. Supplemental Funds
  A progress report is also required on all activities that were supported during the last year by supplemental funds provided through the SPORE program.



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GUIDELINES

SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPOREs)

ORGAN SYSTEMS BRANCH OFFICE OF CENTERS, TRAINING, AND RESOURCES OFFICE OF DEPUTY DIRECTOR FOR EXTRAMURAL SCIENCES NATIONAL CANCER INSTITUTE

June 2001

SECTION I. GENERAL GUIDELINES

SECTION II. SPECIAL INSTRUCTIONS FOR PREPARING A COMPETING SPORE GRANT APPLICATION

SECTION III. SUPPLEMENTAL GUIDELINES FOR PREPARING A NONCOMPETING CONTINUATION SPORE APPLICATION

SECTION I. GENERAL GUIDELINES

SECTION II. SPECIAL INSTRUCTIONS FOR PREPARING A COMPETING SPORE GRANT APPLICATION

SECTION III. SUPPLEMENTAL GUIDELINES FOR PREPARING A NONCOMPETING CONTINUATION SPORE APPLICATION

SPECIALIZED PROGRAMS OF RESEARCH
EXCELLENCE (SPOREs)

ORGAN SYSTEMS BRANCH
OFFICE OF CENTERS, TRAINING, AND RESOURCES
OFFICE OF DEPUTY DIRECTOR FOR EXTRAMURAL SCIENCES
NATIONAL CANCER INSTITUTE